Purpose.This NIH Funding Opportunity Announcement (FOA), supported
by funds provided to the NIH and HRSA under the “Tom
Lantos and Henry Hyde United States Leadership Against HIV/AIDS, Tuberculosis,
and Malaria Reauthorization Act of 2008,” Public
Law 110-293 (more commonly known as the U.S. President’s Emergency Plan for
AIDS Relief [PEPFAR]), invites proposals from foreign Institutions in Sub-Saharan African
countries which receive PEPFAR support (http://www.pepfar.gov/countries/index.htm) and their partners to develop or expand and enhance models
of medical education in Sub-Saharan Africa. These models are intended to support
PEPFAR’s goal of increasing the number of new health care workers by 140,000, strengthen
medical education systems in the countries in which they exist, and build
clinical and research capacity in Africa as part of a retention strategy for
faculty of medical schools and clinical professors.

The strategy
of this initiative is to build human capacity for health in Africa by
strengthening the medical education system in an environment that values and nurtures
research and which will contribute to the sustainability and quality of the
overall effort. These models will also contribute to the sustainability of the
PEPFAR investments through the provision of excellence in clinical training and
the capacity of medical students and faculty to participate in and carry out
multidisciplinary locally driven research (e.g. implementation science and/or clinical,
health services, and operations research) that responds to the health needs of
their communities and country and improves health outcomes for men, women, and
children. In addition to PEPFAR support for strengthening medical education in
African institutions, funds are also being provided from the Office of AIDS
Research (OAR), located within the NIH Office of the
Director, in support of the research capacity building component of this
initiative and building on OAR’s long-term support for NIH efforts to build
sustainable research and training partnerships
between U.S. and African educational and research institutions.

Linked awards that
focus on diseases and priority health areas related to and/or beyond
HIV/AIDS will also be available through the NIH Common Fund
initiative (http://commonfund.nih.gov/), managed by the Office of Strategic
Coordination (OSC), located within the NIH Office of the
Director. These awards are part of the NIH Director’s decision to make global health one of the NIH’s highest
priorities.

Mechanism of Support. This FOA will utilize the NIH Resource-Related Research Project (R24) grant award mechanism for all applications submitted.

Funds Available and Anticipated Number of Awards.The Office of the U.S. Global AIDS Coordinator intends to provide support forfive to ninePEPFAR
focused awards, referred to as “Programmatic”awards in this
FOA,and one Coordinating Center award starting in FY 2010, pending
the number and quality of applications and
availability of funds.The NIH
OAR will also contributefunds in FY
2010 to support the Programmatic awards.

In addition, up to $3
million will be available in FY
2010for awards,
referred to as “Linked” awards in this FOA, which
focus on non-communicable
diseases and/orpriority health areas (e.g.maternal
and child health, women’s health,cardiovascular
disease and stroke, injury, environmental health concerns, and mental health) related
to and/or beyond HIV/AIDS;it is
anticipated that up to sixof theselinkedprogrammaticawards
will be made starting in FY 2010. The Linked
awards will be supported by the NIH Common Fund through the Office of the NIH Director (http://commonfund.nih.gov/) andwill be administered
by the Fogarty International Centeron behalf of the NIH.

Budget and Project
Period. The requested budget
may not exceed$2,000,000 totalcosts per year for either the Programmatic
awards or the CoordinatingCenter award. The Linked awardapplicationbudget may not exceed
$500,000 total costs per year per award.The total project period for all awards may
not exceed five years.

Application Research Strategy Length: The R24 application Research Strategy section may not exceed 12pages,
including tables, graphs, figures, diagrams, and charts. See Table of Page
Limits.

Eligible Project Directors/Principal Investigators (PDs/PIs).Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research resources program are invited to
work with their institution to develop an application. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

Number
of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the
application.

Number
of Applications. Only one application per
institution (normally identified by having a single DUNS number or NIH IPF
number) is allowed for either the Coordinating Center or Programmatic awards,
although applicant institutions may also participate as members of consortia on
applications submitted through other institutions. To be eligible for the Linked
awards, an African institution must have submitted an application for a Programmatic
award; up to two Linked award applications may be submitted per applicant institution
in differing focus areas.

Resubmissions: Resubmission
applications are not permitted in response to this FOA.

Renewals: Renewal
applications are not permitted in response to this FOA.

The Medical Education Partnership
Initiative (MEPI)is a coordinated
effort led by the Office of the U.S. Global AIDS
Coordinator (OGAC) at the Department of State and supported by the National Institutes of Health’s (NIH)Common Fund,the Office of AIDS
Research (OAR), and the Office of Research on
Women’s Health (ORWH) in the Office of the NIH
Director and the Health Resources and Services Administration’s
(HRSA) Administrator. Awards from this initiative will be jointly
managed by NIH and HRSA under the guidance of OGAC in collaboration
with the participating organizations. These awards will provide support
to African institutionsworking in
partnership with a U.S. and/or other African university-based medical school to strengthen and build the
clinical and research capacity ofmedical educational
institutions in Sub-Saharan Africa and thereby help to
strengthen the human capacity for health in Africa. Specifically, applicants should:

1) Propose to expand and/or enhanceinnovative medical education models that have the potential to improve the quality of clinical education and clinical care in countries in Sub-Saharan Africa;

2) Develop strategies that enable graduating medical
students to remain in their home country to practice, serve as faculty, and/or conduct research
related to the implementation of PEPFAR and other public health priorities; and

3) Enhance the
recruitment and retention of qualified academic faculty through partnerships and research opportunities.

Programmatic Awards: MEPI encourages
innovative community-based training, problem-based learning, clinical
preceptorships, and the development of training resources and activities that will provide students and faculty with the
tools, concepts, mentoring, and opportunities that will facilitate innovative
multidisciplinary approaches to medical education. The medical education models
under MEPI should also create opportunities for medical
education to be used as the platform for developing locally driven research (e.g. implementation science and/or
clinical, health services, and operations research) to improve health
outcomes in local communities and countries in Sub-Saharan Africa. The research platform is considered an important
strategy to develop new generations of clinical leaders, retaining experts in
country, and promoting quality clinical practice. The MEPI Programmatic Award
applications must be built on existing partnerships
that contribute to these goals.

As
the programmatic activities of this initiative will support national
strategies, letters of support from the Ministry of Health and Ministry of
Education for each African country with a Programmatic application will be
required. It is highly recommended that these letters of support be included
with the application. If these are submitted later, this could impact and
delay the review of the application. An award will not be made without receipt
of these letters of support.

Linked
Awards: While most of the current global heath investments in
Africa justifiably focus on HIV/AIDS, tuberculosis, and malaria, investments in
other priority health areas (e.g.
maternal and child health, women’s health, cardiovascular disease and stroke, injury, environmental health
concerns, and mental health) and chronic
non-communicable diseases will be critical to supporting health systems
strengthening and reducing levels of morbidity and pre-mature mortality
throughout Sub-Saharan Africa. The NIH Director has identified global health as
an area of significant promise for furthering major advances that can play a
significant role in the development of prevention, diagnostics, and
therapeutics that can reduce the burdens of illness and disability around the
world.

In support of this
interest in global health, the Office
of the NIH Director through the NIH Common Fund, will
provide additional support for programmatic partnerships (Linked Awards) which
help to build research capacity and research training opportunities in other priority
health areas and chronic non-communicable diseases of importance to the
applicant’s country related to and/or beyond HIV/AIDS; some of these diseases
may also be important for HIV/AIDS co-morbidities (e.g. cancer, cardiovascular
disease, mental health, and others).The NIH Common Fund supports
cross-cutting programs that are expected to have exceptionally high impact. All
Common Fund initiatives invite investigators to develop bold, innovative, and
often risky approaches to address problems that may seem intractable or to
seize new opportunities that offer the potential for rapid progress.

The Linked award
applications may support either existing or new partnerships but must be well
integrated with the activities of the related Programmatic award. If the Linked
award application proposes a new relationship, the application must include a
planning phase during the first year of the award. Linked award applications must
be submitted separately from the Programmatic award submissions and will be
individually evaluated and receive a separate score from the applicant’s Programmatic
application. A Linked award will not be made unless the related
Programmatic application is also funded. The Linked awards funded through this
initiative will be administered by the Fogarty International Center (FIC) on behalf of the NIH.

Coordinating Center (CC): Under this FOA a CCwill be awarded to a U.S. institutionwith extensive
knowledge of medical education in Sub-Saharan Africa, experience working with and
documenting medical education practices, and which can demonstrate existing partnerships with
African educational and ministerial leaders. The primary function
of the CC will include coordinating activities across the Programmaticprograms, including Linked awards, and working with
their African partner(s) to develop an African leadership network
to guide, support, and advocate for the effort.TheCC will use this network of African
educational, ministerial,and scientific leaders to share information and
experiences, toevaluate the
educational modelsidentifyingbest practices,to provide technical
assistance to further build capacity,and to promote educational models that demonstrate success
in meeting the objectives of this FOA. The African partner
should be one that has the potential capacity to, either singularly or dually,
function in the CC role and by the end of the
initial 5-year project period substantially contribute to the
sustainability of the initiative.

This FOA will help to achieve the PEPFAR goals to 1) support
training and retention of more than 140,000 new health care workers and 2)
invest in innovative education and build research capacity to increase the
number of highly qualified clinicians, to improve faculty retention, to evaluate
impact, to improve service delivery, and to maximize outcomes (http://www.pepfar.gov/documents/organization/133035.pdf).
MEPI will also help to achieve the NIH Director’s goal to invest in global
health and chronic non-communicable diseases and/or health conditions beyond
HIV/AIDS.

Background: The Tom Lantos and Henry Hyde United States Leadership
Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, has
set a goal to support treatment for 3 million people, prevent more
than 12 million new infections, and care for more than 12 million people -
including 5 million orphans and vulnerable children.

PEPFAR has
called for immediate action to turn the tide of HIV/AIDS in Africa, Asia, and
the Caribbean. The important aspect of PEPFAR’s bold vision is to treat at
least 3 million HIV-infected persons with ART within 10 years. The goal of the
PEPFAR initiative is to provide the resources to organizations with excellent
HIV care and treatment programs to rapidly expand ART for low income
HIV-infected persons in a manner that is consistent with national plans and
policies in Sub-Saharan Africa and the Caribbean, as well as for countries in Central
Asia, Eastern Europe, Latin America, and other countries and areas. Particular
emphasis is on refugee populations or those in post conflict settings in these countries
and in areas with significant or increasing HIV incidence rates. An additional intent is to develop sustainable local
partner capacity to continue these programs and improve health outcomes.

The NIH Director has also
highlighted investment in global health, to include chronic non-communicable
and neglected tropical diseases, as one of his five high priority areas. Support for these areas
through the NIH Director’s Common Fund will build upon and complement PEPFAR goals.

The MEPI approach acknowledges that local health issues in Africa are complex, cross national
borders, and have biomedical, social/political,
technological, legal/regulatory, and economic dimensions that frequently
require novel and integrated solutions. MEPI will support medicaleducation partnerships that
will assist universities in responding to a growing demand
by their faculty and students for more training
and more varied pathways to address critical localclinical and research needs. Participating medical schools within these
institutionsare encouraged to develop multidisciplinary models that incorporatevarious health services disciplines and their respective
schools to include Nursing, Public Health, Arts
and Sciences, Social Sciences, Health Economics, Computer Science, Dentistry, andothers. These
multidisciplinary models, if proposed,should provide both the expertise necessary to address pressing health concerns in
the country, as well as provide career pathways into health research for
students in these disciplines.

The models developed
through MEPIwill address identified gaps in the quality of
medicaleducation, support innovative
medical education models, and build or enhance local health services and biomedical research capacity. The initiative should provide faculty and studentswith an environment that
will challenge them to try novel approaches and seek
out unfamiliar or emerging technologies and complementary
expertise to incorporate into innovative solutions that have the
capacity to be transformative and sustainable. It is expected that this will require
innovative training models and new partnerships
within and beyond the university community and Sub-Saharan Africa.

Objectives: Applicants should propose activities that will build theinfrastructure and
opportunities at the participating institution(s) to improve the
quality of medical education, retain
graduates in their country, and support faculty development as well as opportunities for multidisciplinary locally driven research training for faculty and
students.Specifically, the
objectives of this FOA are as follows:

For the Programmatic Awards:

Programmatic applicants must build on established
partnership(s) (applicants must
discuss how partnerships are part of an existing partnership and/or
relationship) with U.S. and/or African based universities with schools of medicine. Specifically,applicants should propose to:

Develop new training
and career development opportunities for medical students and faculty to engage in
hands-on, community-based, and problem-based clinical education
andresearch training.This should include
clinical preceptorships and may also include fellowships of up to two years or the development of
multidisciplinary fellowship programs, courses, summer institutes, practicum
opportunities, mentored clinical and research experiences,
and others. For the purposes of this initiative, the
target participant population must be at the medical student level or above.Should trainees be
selected for fellowship opportunities, applicants should discuss the plan for
trainee selection, to include an equal opportunity for
men and women, and how these opportunities will
contribute to the success of the applicant’s proposed educational model and the use of an
Advisory Committee to ensure that selected trainees and fellowships are
appropriate for facilitating the objectives of this FOA. The applicant is encouraged to present an innovative
teaching model that includes multidisciplinary clinical education andlocally driven research and training opportunities directed
towards improving local health outcomes. These may include activities in clinical care, prevention, outreach, informatics,
modeling, policy, education, research training, or other opportunities that are appropriate
to developing the infrastructure of the medical school and institution.

Create an enabling
academic environment to promote locally driven research, to include equal opportunities for
women who are faculty and/or students. This environment might be
realized through the challenges providedby training activities; through innovative curriculum development, to include pre-med
curriculum; through clinical
preceptorships andmentoring; through the development of a
physical or virtual space that allows multidisciplinary teams of students to
work on projects together; through the creation of
electronic tools to facilitate multi-site or
multi-country multidisciplinary education and research networks; through developing courses using distance learning
pedagogy; or through many other means. Opportunities might also be developed to
enhance expertise in research integrity, ethical
review, financial management, grants management and administration to
include (but not be limited to) bioethics, IRBs, and how to search for, apply for,and administer grants so that a strong infrastructure for supporting research at the
institution may be created. The applicant should
also consider addressing how grants administration at the institution could be improved
and how selected partners might be involved.

Developeducational models which have the
potential to demonstrate a sustainable increase in the recruitment and retention of medical students andacademic faculty, to include women;an increase in the number of
graduating medical students who begin local practice, become members of academic faculty, and/or conduct research
related to the implementation of PEPFAR and other
public health priorities in the home country;and encourage institutional support oflocal research efforts.

Participate in annual granteemeetings and site
visits organized by the Coordinating Center.

For the Linked Awards:

Building on the objectives of the Programmatic awards,
the Linkedawards will provide
additional funding to selected Programmatic awardees at the same
institution to support research capacity
building and research training in other priority health areas(e.g. maternal and child health, women’s health, cardiovascular
disease and stroke, injury, environmental health
concerns, and mental health) and chronic non-communicable diseases related to and/or beyond HIV/AIDS. The Linked awards will be funded as separate, but administratively linked,
to the Principal Investigator(s) of the Programmatic Awards (e.g. the same
contact PI). In contrast to the Programmatic awards which must be built on existing
relationships,
these awards may be used to support either existing or new partnerships that will contribute to health
systems strengthening and the use of research to improve
treatment, identify preventative measures, and groom future generations of
scientists who can ultimately improve the health outcomes related to these
areas in the applicant’s community and country. Specifically, applicants should
propose to:

Substantially increase the
expertise of faculty and students in chronic non-communicable diseases and/or
other health priorities related to and/or beyond HIV/AIDS which significantly
impact morbidity and pre-mature mortality in the applicant’s community and
country.

Strengthen the implementation and
sustainability of education and research training related to chronic
non-communicable diseases, co-morbidities between infectious and
non-communicable diseases, and/or the integration of infectious and
non-communicable disease management at the applicant’s institution and/or
consortium.

Strengthen faculty contributions and
student participation in medical education and locally driven research for
chronic non-communicable diseases, as well as other priority, locally relevant
health issues to include sex and gender factors in health and disease, and encourage
creative and innovative teaching, mentoring, and research training models to
support addressing these priorities.

The Coordinating Center
(CC)will act as a source of technical
support for all aspects of the multi-site initiative to include the implementation of activities,
refinements to educational models, training, establishing quality control
mechanisms, and dissemination of project results. As such, the CC must have an in-depth knowledge of evaluation(including impact
evaluation), medical education, research training, and public health
priorities across Sub-Saharan Africa.

The CC will perform a needs
assessment across all sites within the first 6 months of the initiative;if appropriate, develop working
groups to respond to identified gaps (e.g. informatics, research training, grants administration, and others); and provide specific
technical support via listservs, discussions, and periodic meetings. The CC will also
assist the sites in developing output, outcome, and impact metrics that will guide data collection, monitoring, and
evaluation activities.

The CC is expected to
provide sound methodological consultation and technical assistance to achieve
scientific excellence and improve the quality of medical education, medical research, and ultimately medical care. As
such, the CC must be able to guide actions necessaryto assist programmatic
sites to design and conduct evaluationsand identify the technical assistance
needs of the Programmaticand Linkedawardees. The CC is also
expected to utilize an evaluation framework to
conduct an overall evaluation of the entire program including its processes,
outputs, outcomes, and impacts. Process evaluations of MEPI should be conducted
annually with a comprehensive outcome evaluation to be completed by the final year of theaward.

In collaboration with
the programmatic awardees, the CC must develop a
Web-based data system for the collection of output, outcome, and impact data elements
related to MEPI. This may include (but not be limited to) tracking medical curriculum
development, faculty training and retention, local health professional’s training and
retention, and students trained at Programmaticand Linked award sites. The CC is also
expected to assist African institutions funded under this initiative with tracking trainees’ careers as a part of
the web-based data system. The FIC will
make CareerTrac (https://careertrac.fic.nih.gov/Welcome.vm) available to both the CC and programmatic sites to be used for this purpose if appropriate.

The CC will coordinategrantee meetings,
site visits, and conference calls. At a minimum, one site visit assessment with each Programmatic and Linkedawardees’ site and onegranteemeeting per year
involving all Programmatic and Linked awardees will be held in Sub-SaharanAfrica or another venue
identified by awarding agencyprogram staff.

The CC will act as a source
of technical assistance to participating countries on developing
national policies with Ministries of Health and
Education, network development, developing public-private partnerships, and developing
coalitions and networks to support the
advancement of medicaleducation and health
services research in Sub-SaharanAfrica.As such, it is expected that the African partner selected can provide the
necessary support and linkages to other African leaders, institutions, and
organizations that can be of assistance
in moving the initiative forward. The African partner should also be one who
has the potential to, either singularly or dually,
function in the CC role by the end of the initial 5-year project period and substantially contribute to the
sustainability of the initiative.

In addition to providing technical
assistance to the individual site evaluations, the CC will also be expected to conduct focused
evaluation studies (e.g. impact evaluations). Topics will be
generated by the CC in collaboration with Programmatic and Linked awardees, NIH, HRSA, and OGAC.

The CC Principal Investigator is
expected to be in frequent communication with NIH and
HRSA program staff.

Scope: The proposed activities for the programmatic awards should address the health
concerns of populations living in the applicant’s home country and other low and middle
income countries within the consortium
as applicable. The applicant should
provide a discussion of available resources and a needs assessment for
medical education in their country. The applicant should build on
existing partnerships but may also propose completely
new activities or build significantly on initiatives
already in place at the university that will take these initiatives to a new
level or result in a new use of available resources. The applicant should not propose to merely
sustain an initiative already in place. Projects may
also benefit from integration with other PEPFAR-fundedcare and treatment programs, educational programs, research, and research
training.

Participants and Consortia: The application
must include the participation of at least one partner outside of the applicant institution. For the Programmatic awards, an existing partnership with at least one U.S. based institution and/or another
African based medical education program must be demonstrated.The CoordinatingCenterpartnerships must be with organizations or institutions in PEPFAR funded Sub-Saharan African countries which are not
otherwise involved in the Programmatic or Linked award applications. Partnerships should contribute to the probability of success of applicants
in meeting the objectives of this FOA, as well as
provide support for capacity building
efforts and contribute to addressing applicants’ technical
assistance needs (e.g. supporting capacity
building efforts in administration, management, financing, education, and/or research) and should provide a
benefit for all participants. Applicants for any MEPI award must demonstrate
experience in managing global health grants, contracts, and/or cooperative
agreements. Applicants and their partners should be
committed to sharing resources and curricula using modern information technology.

Applicants and or consortia partners may only be funded as 1)
partners of both the Programmatic and Linked awards or 2) as the Coordinating Center; institutions and organizations may not participate in both
capacities.

Interests of Participating Organizations:

The Office of the U.S. Global AIDS
Coordinator (OGAC) is appointed by the President and confirmed by the Senate
to coordinate and oversee the U.S. global response to HIV/AIDS. Reporting
directly to the Secretary of State, OGAC leads the U.S. Government's (USG)
international HIV/AIDS efforts; ensures program and policy coordination among
the relevant USG agencies and departments and nongovernmental organizations,
avoiding duplication of effort; pursues coordination with other countries and
international organizations; resolves policy, program, and funding disputes
among the relevant USG agencies and departments; directly approves all
activities of the United States relating to combating HIV/AIDS in developing countries;
and promotes program accountability and monitors progress toward meeting
PEPFAR's goals.

OGAC is interested in
supporting programs which help to meet its goals to support HIV/AIDS treatment
for 3 million people, prevent more than 12 million new infections, and care for
more than 12 million people affected by HIV/AIDS and to work toward achieving
these goals by training and supporting retention of 140,000 new health care
workers.

The National Institutes of Health (NIH)is the primary U.S. Federal agency for
conducting and supporting biomedical research. The NIH helps to lead the way
toward important medical discoveries that improve health and save lives. NIH-supported
scientists investigate ways to prevent disease as well as the causes, treatments,
and even cures for common and rare diseases. Building capacity and research
training opportunities in the developing world is part of the NIH global health
response to the growing challenge of chronic non-communicable diseases and
injury, in addition to the global health research already being conducted in HIV/AIDS,
tuberculosis, and malaria.

The Office of Strategic Coordination (OSC), located within
the NIH Office of the Director, manages the Common Fund, which supports cross-cutting programs that are expected to have
exceptionally high impact. All Common Fund initiatives invite investigators to
develop bold, innovative, and often risky approaches to address problems that
may seem intractable or to seize new opportunities that offer the potential for
rapid progress.

The Office of AIDS Research (OAR), located within the NIH
Office of the Director, coordinates the scientific, budgetary, legislative, and
policy elements of NIH AIDS research. The NIH represents the largest and most
significant public investment in AIDS research in the world. OAR has a history
of supporting NIH programs to build long-term research and research training
partnerships between institutions in the U.S. and in Sub-Saharan Africa.

The
Office of Research on Women’s Health (ORWH), located within the NIH Office of
the Director, stimulates, encourages, and supports meritorious research on
women’s health and sex and gender factors in health and disease. ORWH also
ensures the inclusion of women and minorities in NIH clinical research and
promotes the recruitment, retention, re-entry, and advancement of women in
biomedical careers.

The Fogarty International Center
(FIC) supports and conducts Global Health research training and research across the spectrum of health sciences in the U.S. and abroad. FIC, the international component of the
NIH, addresses Global Health challenges through innovative and collaborative research and research training programs, and
supports and advances the NIH mission through international partnerships. FIC also supports an extensive network of
programs to build HIV/AIDS research capacity in low and middle income
countries, including many countries in Africa.

The Health Resources and Services
Administration (HRSA) is the primary Federal agency for improving access to
quality health care services for people who are uninsured, isolated, or
medically vulnerable in the United States. HRSA provides leadership and
financial support to address challenges in maternal and child health, health
professional workforce development, HIV/AIDS, and other critical health/medical
sectors through its six Bureaus and 13 Offices.

Through the Bureau of Health Professions, HRSA
has taken a leadership role in supporting health professions workforce
development in the U.S. The HRSA-supported grantees have trained health
professionals, improved care systems, and developed medical and nursing
curricula. In addition, the Bureau of Health Professions has led the study of
current issues affecting the physician workforce, surveyed the registered nurse
population, and provided grants to address healthcare workforce unmet needs.

The HIV/AIDS Bureau (HAB)administers one of the largest
federally funded domestic HIV/AIDS Programs, the
Ryan White Program, for HRSA. The Ryan White Program provides HIV-related
services to more than half a million people each year. The program is for those
who do not have sufficient health care coverage or financial resources for
coping with HIV disease. Ryan White fills gaps in care not covered by other
sources. The Global HIV/AIDS Program is the international office of HAB working through
PEPFAR to strengthen clinical
and administrative systems and services to build networks of comprehensive
HIV/AIDS care and treatment; design innovative care and support models to remove
barriers to care and treatment; strengthen quality improvement integration to
enhance clinical services; support training activities and partnerships to
develop human and organizational capacity; assess the effectiveness of specific
models of care to promote adaptation of best practices; and enhance the
capacity of its partners to collect, monitor, and evaluate data for quality HIV/AIDS
health services.

This funding
opportunity will use theNIH Resource-Related
Research Project (R24) award mechanism for
all applications, which is
a flexible and specialized mechanism designed to provide resources to address
problems where multiple expertise is needed to focus on a single complex
problem in research or to enhance research infrastructure. The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.

This initiative is supported by
funds provided to the NIH and HRSA under the “Tom Lantos and Henry Hyde
United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria
Reauthorization Act of 2008,” Public Law
110-293 (more commonly known as the U.S. President’s Emergency Plan for AIDS
Relief [PEPFAR]). OGAC intends to provide support for five to nineProgrammatic grants
and one Coordinating Center, contingent upon receipt of a sufficient number of
scientifically meritorious applications starting in FY 2010. The NIH OAR will also
contribute funds in FY 2010 to support the
Programmatic awards. In addition, up to $3 millionwill be available for up to six programmatic (Linked)awards under this FOA that will focus on non-communicable diseases and priority health areasrelated to and/or beyond HIV/AIDS. TheseLinked awards will be supported as a Common
Fund initiative through the Office of the NIH
Director.

Budget proposals for the Coordinating Center and Programmatic
applications are limited to $2,000,000total costs per year per applicant with a project period not greater than five years. Coordinating Center applicants must partner with at least one African institution or organization based in a
Sub-Saharan African country which receives PEPFAR support; the African partners
to the CC are not eligible to participate in either the Programmatic or Linked
awards. Programmatic applicants must partner with at least one U.S. and/or African institution outside the applicant university. For the Programmatic
applications, the funding agencies expect that beginning with the first year the
majority of funds will be expended at the foreign site with an increasing
amount of funds spent at the foreign site in subsequent years.

The Linked applications may not exceed $500,000 total costs per year per award and must not exceed the project period of the associated Programmatic award. Linked
applications must be submitted by the same Institution and Contact PI as the
Programmatic application. For the Linked applications, the funding agencies
expect that beginning with the first year the majority of funds will be
expended at the foreign site with an increasing amount of funds spent at the
foreign site in subsequent years.

Alterations and renovations are allowable costs for only
the Programmatic applications. Alterations and renovations are allowable for up
to $75,000 direct costs over the life of the project. Alterations and
renovations must be clearly justified and in direct support of the activities
proposed for this initiative. All alterations and renovations must be requested
specifically and approved by the awarding agency.

Programmatic and Linked awards can request up to 8% of
total direct costs (less equipment) within the total cost cap.

Because
the nature and scope of the proposed
resource-related research program will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of theFunding Agencies and the IC(s)provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications.

Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.

NIH
grants policies as described in the NIH Grants Policy
Statement will apply to the applications submitted and awards made in
response to this FOA.

Section
III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The
following organizations/institutions are eligible to apply.

For the Programmatic and LinkedAwards:

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Specifically:

The following foreign institutions with a
medical school and based in a
Sub-Saharan African country which
receives PEPFAR support (http://www.pepfar.gov/countries/index.htm) are
eligible for the Programmaticand Linkedawards:

Public/State
Controlled Institutions of Higher Education

Private
Institutions of Higher Education

For the Coordinating Center:

U.S.Public/State
Controlled Institutions of Higher Education

U.S. Private Institutions
of Higher Education

1.B.
Eligible Individuals

The
following applies to applicants for each Programmatic and Linked Award as well
as the Coordinating Center.

Any individual(s) with the
skills, knowledge, and resources necessary to carry out the proposed research
resources program as the PD/PI is invited to work with his/her organization to
develop an application. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

The PD/PI should be an established
leader in the academic and scientific area in which the application is targeted
and capable of providing administrative, clinical, and scientific leadership to
the development and implementation of the proposed program.

More than one PD/PI (i.e.,
multiple PDs/PIs), may be designated on the application for projects that
require a “team science” approach and therefore clearly do not fit the
single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi.All PDs/PIs must be registered in the NIH electronic
Research Administration (eRA) Commons prior to the submission of the
application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to
apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility
of the investigators and applicant organizations and should be determined by
the scientific goals of the project. Applications for grants with multiple
PDs/PIs will require additional information, as outlined in the instructions
below. When considering the multiple PD/PI option, please be aware that the
structure and governance of the PD/PI leadership team as well as the knowledge,
skills and experience of the individual PDs/PIs will be factored into the
assessment of the overall scientific merit of the application. Multiple
PDs/PIs on a project share the authority and responsibility for leading and
directing the project, intellectually and logistically. Each PD/PI is
responsible and accountable to the grantee organization, or, as appropriate, to
a collaborating organization, for the proper conduct of the project or program,
including the submission of required reports. For further information on
multiple PDs/PIs, please seehttp://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.In the case of Linked
awards who partner with NIH intramural programs this does not apply, as the
Scientific Director of the collaborating institute or center must commit
resources from the NIH institute or center.

3. Other-Special Eligibility Criteria

Number of Applications. The initiative will fund only one
Programmatic award or Coordinating Center application to any single
institution. However, applicant institutions may also participate in consortia
through applications submitted by other institutions as long as the programs
are scientifically and programmatically distinct. Applicants and/or consortia
partners may only be funded as partners of either the programmatic awards or the
Coordinating Center; institutions and organizations may not participate in
both capacities. Applicants to the Linked awards must also apply to the Programmatic
award and be selected for funding as a Programmatic awardee to be eligible to receive
a Linked award.

Resubmissions. Resubmission applications are not permitted in response to
this FOA.

Renewals. Renewal applications are not permitted in response to this
FOA.

Developing country collaboration: Primaryconsortia members may include collaborating
institutions and organizations from the U.S. and other countries in Sub-Saharan Africa which receive PEPFAR support (http://www.pepfar.gov/countries/index.htm).Partners from other geographic
regions may be part of a consortium arrangement if they add value to the
overall project.

Pre-requisite activities in Global Health: Institutions are eligible to apply if they can
demonstrate that the applicant institution and its partners are collectively
involved in a minimum of five active global health (to include PEPFAR-funded)
grants, cooperative agreements, contracts, or awards from the U.S. government (USG) (e.g. CDC, DOD, HRSA, NIH, USAID, and others) or non - USG funders (e.g.
Wellcome Trust, Doris Duke, Gates Foundation, and others) involving low and
middle income countries. At least two awards must be research or research
training grants, cooperative agreements, or research contracts in Global Health
areas important to the public health concerns of the applicant’s country; at
least one of these awards must be from the NIH. These awards must be active
on the application receipt date for this FOA. The institution may be the
direct recipient of the award or may be the foreign component/subcontract on an
award to another institution or be a listed collaborating site for an existing
FIC research training or other capacity building award. Alternatively, if a
consortium of institutions applies as partners, the institutions applying must
together meet this pre-requisite (i.e. as the sum of global health awards to all
the partners).

Applications must have a
D&B Data Universal Numbering System (DUNS) number as the universal identifier
when applying for Federal grants or cooperative agreements. The D&B number
can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.

Every effort should be made to comply with the
format specifications, which are based upon a standard U.S. paper size of 8.5” x 11”.

Funds for up to 8% Facilities and Administrative
(F&A) costs (excluding equipment, tuition, and fees) may be requested.
SeeNOT-OD-01-028, March 29, 2001.

Organizations must comply with Federal/NIH
policies on human subjects, animals, and biohazards.

Organizations must comply with Federal/NIH
biosafety and biosecurity regulations. See Section VI.2.,
“Administrative and National Policy Requirements”

Applications with
Multiple PDs/PIs

The following applies to
applicants for each Programmatic and Linked Award as well as the Coordinating Center.

When multiple PD/PIs are
proposed, use the Face Page-Continued page to provide items 3a – 3h for all
PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all
communications between the PD/PIs and the agency. The contact PD/PI must meet
all eligibility requirements for PD/PI status in the same way as other PD/PIs,
but has no special roles or responsibilities within the project team beyond
those mentioned above. The contact PD/PI may be changed during the project
period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face
Page), with all additional PD/PIs listed on Form Page 1-Continued. When
inserting the name of the PD/PI in the header of each application page, use the
name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the
applicant organization if PD/PIs are from more than one institution.

All individuals designated
as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI
role in that system (other roles such as SO or IAR will not give the PD/PI the
appropriate access to the application records). Each PD/PI must include their
respective eRA Commons ID in the eRA Commons User Name field.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section
of the Research Plan entitled “Multiple PD/PI Leadership Plan”, must be
included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership team
and the research project should be described, and should include communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts. The roles and administrative, technical, and
scientific responsibilities for the project or program should be delineated for
the PDs/PIs and other collaborators.

Prospective
applicants are strongly encouraged to submit a letter of intent (LOI) that
includes the following information:

Descriptive title of proposed research resources
program and the award(s) (Programmatic, Linked, or Coordinating Center) applying to.

Name, address, and telephone number of the
PD(s)/PI(s).

Names of other key personnel.

Participating institutions.

Number and title of this funding opportunity.

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows NIH
staff to estimate and plan for the potential review workload.

Applications
must be prepared using the forms found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and five signed photocopies in one package to:

Applications
must be received on or before the application receipt date (adherence to the
application receipt date will be strictly enforced) described above (Section IV.3.A.). If an application is received after
that date, the application may be delayed in the review process or not
reviewed. Upon receipt, applications will be evaluated for completeness by the
CSR and for responsiveness by the issuing organization. Incomplete and/or
non-responsive applications will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants
Policy Statement(http://grants.nih.gov/grants/policy/policy.htm).

6. Other Submission Requirements

The purpose of this FOA is to create opportunities and
resources to strengthen medical education and multidisciplinary training for
innovation in locally
driven research in
Sub-Saharan African institutions in countries which receive PEPFAR support and
to strengthen human capacity for health in Africa. It is expected that additional
schools (e.g., nursing, public health, social sciences, computer science, dentistry,
and others) within the university might work together, and some applicants may
put together consortia of institutions to jointly develop training and resource
plans. As such, within the research resources program plan, applicants should
also address the following:

Describe
how the faculty from different Schools, Departments, and Institutions (where
applicable) will communicate and coordinate their efforts on this program.

Describe
any barriers to the implementation of the proposed plan (administrative or
other) and how these might be overcome.

For
consortia, explain why the particular partnerships were chosen, how they add
value to the proposed program, and why these partners have the potential to
successfully develop a program together.

Where
this initiative will be integrated with other ongoing initiatives at the
institution(s) or in the country (e.g. Global Fund, Wellcome Trust, Gates
Foundation, Doris Duke, Millennium Villages, and others), explain the
relationship of the projects, the proposed value added if this grant is
awarded, and how duplication will be minimized and synergies enhanced.

Address how the proposed activities might be catalytic and
lead to a sustained opportunity at the institution(s) and within the country.

If a Programmatic applicant is also
applying for a Linked award, explain how
the Linked award will be closely integrated
and coordinated with the Programmatic award.

Institutional Commitment:
Applications should include letters from the University President, Dean or
Director of the Medical School, and the head research administrator or
equivalent at all participating institutions (for the Coordinating Center,
letters should be included from the participating institutions’ leadership [to
include the University President and Dean or Director of the Medical School] as
appropriate) substantiating the institution’s commitment to the proposed
research resource development and to sustaining the results of the proposed
activities. The institution should state their commitment to overcoming any
administrative obstacles to the implementation of the proposal, such as
accommodation for participation by multiple Schools at the university or
collaboration with other institutions. Appropriate institutional commitment to the program
includes the provision of adequate staff, facilities, and resources that can
contribute to the planned program.

Monitoring and Evaluation Plan: Programmatic, Linked, and Coordinating Center applications must contain a monitoring and evaluation plan for the
institution’s award and activities supported by this FOA. Applications should include goals,
objectives, and metrics and take into account the need for an annual evaluation.
Applications should discuss how the project will be assessed and how each
applicant will define, identify, and determine impact and implement modifications
to improve program impact. Monitoring and evaluation activities should generate sufficient information to
assess the project’s sustainability and specifically whether the project’s
initiation will have a strong likelihood of being continued and supported by
the country’s Ministries of Health and Education and other institutions in the
country or region as appropriate.

Programmatic applicants, to include
Linked award applicants, must also establish a plan to participate in site
visits, grantee meetings, and collaborate on an overall evaluation with the Coordinating Center.

Linked Awards: The contact Principal Investigator
for a Linked award application must be the same as the contact Principal
Investigator of the Programmatic application. The time period for the proposed Linked
award may not exceed the Programmatic award project period. The Linked
award applications must be written and submitted as a separate application,
including a Research Strategy that adheres to the page limitation of 12
pages (See: http://enhancing-peer-review.nih.gov/page_limits.html). The application should also include:

A detailed explanation of the scientific and
administrative relationship between the Linked award activities proposed
and the objectives of the Programmatic award;

A needs assessment for the proposed activities of the Linked
award;

A detailed discussion as to how the objectives of the Linked
award will be accomplished and also integrate with and enhance the
activities of the Programmatic award and the health system of the
applicant’s country;

A detailed explanation about how the partnerships established
in the Linked award application (new or existing) will enhance and
strengthen the project. Specifically, how partnerships might be utilized
to enhance and coordinate country and subject area efforts in medical
education and research; and

A non-modular budget.

PHS398 Research Plan
Component Sections

All
application instructions outlined in the PHS398 Application Guide are to be
followed, with the following additional requirements:

Specific
Aims is limited to 1 page.

Research
Strategy, including tables, graphs, figures, diagrams, and charts is limited to 12 pages. See Table of Page
Limits.

Do not use the Appendix to circumvent the
page limitations. An application that does not observe the required page
limitations may be delayed or disqualified from the review process.

Pre-requisite activities in Global Health: Applicants must provide a Table in the appendix that
lists the qualifying Global Health grants, cooperative agreements, and/or
contracts from all collaborating institutions to meet the eligibility
requirements (Section III.3), including the following information: source of
funding; name of PD/PI; institution holding the award; grant, cooperative
agreement, or contract number; total amount of award; and end date. If there
are questions about an institution’s (or consortium’s) eligibility, please
contact the FIC Scientific Contact (Section VII.1)

No supplemental/update information will be accepted. The
only exception will be letters of support from the Ministries of Health or
Education.

Training in the Responsible Conduct
of Research:Every trainee supported by this research resources grant
must receive instruction in the responsible conduct of research. All
Applications must include a plan to provide such instruction as part of the
research strategy. The plan must address five components: format; subject
matter; faculty participation; duration of instruction; and frequency of
instruction as detailed in NOT-OD-10-019. Applications
lacking a plan for instruction in responsible conduct of research will be
considered incomplete and may be delayed in the review process. The
background, rationale and more detail about instruction in the responsible
conduct of research can be found in NOT-OD-10-019.
See http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html.

Students who will participate in research training involving
human subjects must meet the NIH policy requirement for education in human subjects’
protections (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html).
Students participating in research training with live vertebrate animals must
also be enrolled in the institutional animal welfare training program for
personnel who have contact with animals. The requirements for specific human subjects’
education and participation in the institutional animal welfare training
program may be included as elements of required training in the Responsible
conduct of Research.

All Institutions: Failure to meet the
following criteria at the time of application will disqualify the application
from consideration:

For the Programmatic Awards:

1. The Face Page and Specific Aims section of the application
clearly identifies the specific award (Programmatic) the application is in
response to. On the Face Page, block “1” should begin with “Programmatic:” and
then followed by the specific title.

3. The applicant institution is in a Sub-Saharan African
country which receives PEPFAR support and has attached
documentation of the pre-requisite number and type of currently funded Global
Health awards (see Section III, 3 below);

4. At least one partner, U.S. and/or African based, which strengthens the technical
merit of the application is included as a participant
(the applicant must discuss how the partner is part of an existing partnership
or relationship with the applicant institution);

5. Appropriate letters of support from participating University leadership
(Specifically letters from the University President,
Dean or Director of the Medical School, and Dean or Director of Research or an appropriate
equivalent) are included;

6. Appropriate letters of support from the Ministry of Health
and Ministry of Education are included;

7. The budget is within the cost
cap; and

8. An innovative model of medical education, including
building capacity for research and clinical training, is proposed.

For the Linked Awards:

1. The Face Page and
Specific Aims section of the application clearly identifies the specific award (Linked) the application is in response to. On the
Face Page, block “1” should begin with “Linked:” and then followed by the
specific title.

3. The applicant
institution has applied to and meets the above Programmatic Awards criteria; up to
two Linked award applications may be submitted per institution in differing
focus areas. If two applications are submitted, one must be in a
non-communicable disease area. Linked applications must be submitted by the
same Institution and Contact PI as the Programmatic application.

4. The budget is within the cost cap; and

5. An innovative model of medical education, including building capacity for research and clinical training,
focusing on priority health issues and/or non-communicable diseases related to
and/or beyond HIV/AIDS in the applicant’s community and country is proposed and
which demonstrates linkage to the Programmatic award.

For the Coordinating Center:

1. The Face Page and Specific Aims section of the application
clearly identifies the specific award (Coordinating Center) the application is in response to. On the Face Page,
block “1” should begin with “Coordinating Center:” and then followed by the specific title.

3. The applicant institution has
attached documentation of the pre-requisite number and type of currently funded
Global Health awards (see Section III, 3 below);

4. At least one African partner in a Sub-Saharan African
country which receives PEPFAR support, which strengthens
the technical merit of the application, is included
as a participant (the African partner(s)
must not be applying as a primary applicant or consortia partner of the
Programmatic or Linked awards). The applicant must discuss how
the partner is part of an existing partnership or
relationship with the applicant institution.

5. Appropriate letters of support from the participating institutions’ leadership(to include the University President and Dean or Director of
the Medical School); and

6. The budget is within
the cost cap.

Resource Sharing
Plan(s)

NIH considers the
sharing of unique research resources developed through NIH-sponsored research
an important means to enhance the value of, and advance research. When
resources have been developed with NIH funds and the associated research
findings published or provided to NIH, it is important that they be made
readily available for research purposes to qualified individuals within the
scientific community. If the final data/resources are
not amenable to sharing, this must be explained in Resource Sharing section of
the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan:
Investigators seeking $500,000 or more in direct costs in any year are expected
to include a brief 1-paragraph description of how final research data (including
curricula) will be shared, or explain why data-sharing is not possible.Applicants are encouraged to discuss data-sharing
plans with their NIH program contact. See Data-Sharing
Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model organisms
and related resources, or state appropriate reasons why such sharing is
restricted or not possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless
of the amount requested, applicants seeking funding for a genome-wide
association study are expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A
genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (such as blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy for Sharing
of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section
V. Application Review Information

1. Criteria

Only
the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are
complete and
responsive to this FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the Center for
Scientific Review (CSR)and in
accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned an impact/priority
score;

Receive a written critique; and

Subsequent to the peer
review, applications deemed meritorious will receive a second level of review
by the FIC Advisory Board and the Advisory Council or
Advisory Boards of co-funding NIH Institutes and Centers or Participating Organizations.

The mission of the NIH is to support science
in pursuit of knowledge about the biology and behavior of living systems and to
apply that knowledge to extend healthy life and reduce the burdens of illness
and disability. As part of this mission, applications submitted to the NIH
for grants or cooperative agreements to support biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall
impact/priority score to reflect their assessment of the likelihood for the
research resources program (Programmatic, Linked, and Coordinating Center
applications) to exert a sustained, powerful influence on the research
fields involved, in consideration of the following five scored review criteria,
and additional review criteria (as applicable for the program proposed).

For the Programmatic Awards:

Scored Review Criteria

Reviewers will consider each of the five
review criteria below in the determination of scientific and technical merit,
and give a separate score for each. An application does not need to be
strong in all categories to be judged likely to have major impact.

Significance. Does the project address an important problem or a
critical barrier to progress in medical education? If the aims of the
project are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of
the aims change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field? How does the research resources program proposed remove critical barriers to
progress in implementation of PEPFAR and other public health priorities? How will the program be transformative and
sustainable for the participating schools and institutions?

Investigator(s). Are the PD/PIs, collaborators, and
other researchers well suited to the project? If Early Stage
Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If
established, have they demonstrated an ongoing record of accomplishments that
have advanced their field(s)? If the project is collaborative or multi-PD/PI,
do the investigators have complementary and integrated expertise; are their
leadership approach, governance and organizational structure appropriate for
the project? How will the
past collaborations of the investigators (and their institutions) contribute to
the likelihood of success in the proposed program?

Innovation. Does
the application challenge and seek to shift current research or clinical
practice paradigms by utilizing novel theoretical concepts, approaches or
methodologies, instrumentation, or interventions? Are the concepts,
approaches or methodologies, instrumentation, or interventions novel to one
field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?How does the program promote and support “innovation”that will strengthenmedical
education and health services research? How will all participating entities, both among the components of
the university andwithin the partnership or a
consortium (where applicable), contribute to the innovation goals of the proposal?

Approach. Are the overall strategy, methodology,
and analyses well-reasoned and appropriate to accomplish the specific aims of
the project? Are potential problems, alternative strategies, and
benchmarks for success presented? If the project is in the early
stages of development, will the strategy establish feasibility and will
particularly risky aspects be managed? If the project involves clinical research,
are the plans for 1) protection of human subjects from research risks, and 2)
inclusion of minorities and members of both sexes/genders, as well as the
inclusion of children, justified in terms of the scientific goals and research
strategy proposed? How will the
applicant’s strategy and experience in returning/keeping trainees and faculty
in the host country be amenable to scale-up and sustainability? Do the applicants include a plan for trainee
selection and, if so, how will the function and membership of a trainee
advisory committee support the identification of training needs, programs, and
appropriate trainees? How will other resources and funders at the institutions be
involved? How do the other participating
disciplines and/or institutions and their previous collaborations contribute to
the likelihood of success? How will the activities initiated under this award be
sustained at the conclusion of the five-year award period?

Environment. Will the scientific environment in which the work will be
done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? How is the proposed partnership a previously existing
partnership or collaboration between the Applicant University and selected
partner(s)? How does the applicant identify
and plan to take advantage of other resources at their institution or in their
country (e.g. Global Fund, Wellcome Trust, Gates Foundation, Doris Duke, Millennium Villages, and others)?

For the Linked Awards:

Scored Review Criteria. Reviewers will consider each of the five review criteria
below in the determination of scientific and technical merit, and give a
separate score for each. An application does not need to be strong in all
categories to be judged likely to have major impact.

Significance. Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change
the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? How does
the program provide new training opportunities, new training models, and new
resources for multidisciplinary research on the health concerns of the local community and country at the institution(s) related to and/or
beyond HIV/AIDS? How will collaborations with existing programs in the country
or region be included so as not to duplicate but to coordinate efforts? How will
the program be transformative and sustainable for the participating schools and
institutions?

Investigator(s). Are the PD/PIs, collaborators, and
other researchers well suited to the project? If Early Stage
Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If
established, have they demonstrated an ongoing record of accomplishments that
have advanced their field(s)? If the project is collaborative or
multi-PD/PI, do the investigators have complementary and integrated expertise;
are their leadership approach, governance and organizational structure
appropriate for the project?

Innovation. Does
the application challenge and seek to shift current research or clinical
practice paradigms by utilizing novel theoretical concepts, approaches or
methodologies, instrumentation, or interventions? Are the concepts,
approaches or methodologies, instrumentation, or interventions novel to one
field of research or novel in a broad sense? Is a refinement, improvement,
or new application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?How does the program propose innovative ways to integrate
training and research across disease and health areas to address strengthening the health system as a whole?

Approach. Are the overall strategy, methodology,
and analyses well-reasoned and appropriate to accomplish the specific aims of
the project? Are potential problems, alternative strategies, and
benchmarks for success presented? If the project is in the early
stages of development, will the strategy establish feasibility and will
particularly risky aspects be managed? If the project involves clinical
research, are the plans for 1) protection of human subjects from research
risks, and 2) inclusion of minorities and members of both sexes/genders, as
well as the inclusion of children, justified in terms of the scientific goals
and research strategy proposed? How
does the program take advantage of local health research expertise in non-communicable
diseases and other priority health areas related to and/or beyond HIV/AIDS at
the participating institution(s)? Do the applicants include a plan for trainee
selection and, if so, how will the function and membership of a trainee
advisory committee support the identification of training needs, programs, and
appropriate trainees? How will other resources and funders at the institutions be
involved? How do the other participating disciplines and/or institutions and their
collaborations contribute to the likelihood of success? How will the activities
initiated under this award be sustained at the conclusion of the five-year
award period?

Environment. Will the scientific environment in which the work will be
done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? How is the Linked award proposal integrated and
coordinated with the Programmatic proposal?

For the Coordinating Center:

Scored Review Criteria. Reviewers will consider each of the five review criteria
below in the determination of scientific and technical merit, and give a
separate score for each. An application does not need to be strong in all
categories to be judged likely to have major impact.

Significance. Does the project address an important problem or a critical
barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change
the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? How do the proposed role, activities, and value added as a
consultation resource/Coordinating Center contribute to the initiative? How
will the applicant provide leadership and sound methodological consultation to Programmatic
and Linked awardees’ sites? Does the application demonstrate in-depth knowledge
of medical education and an in-depth understanding of the public health
priorities across Sub-Saharan Africa?

Investigator(s). Are the PD/PIs, collaborators, and
other researchers well suited to the project? If Early Stage
Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If established,
have they demonstrated an ongoing record of accomplishments that have advanced
their field(s)? If the project is collaborative or multi-PD/PI, do the
investigators have complementary and integrated expertise; are their leadership
approach, governance and organizational structure appropriate for the project? How
will the investigators (and their
institutions) and/or selected partners previous collaborations increase the
likelihood of success in the proposed program?

Innovation.Does the application challenge and seek
to shift current research or clinical practice paradigms by utilizing novel
theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies,
instrumentation, or interventions novel to one field of research or novel in a
broad sense? Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies, instrumentation, or
interventions proposed?Does
the applicant have the ability to develop a web-based system to adequately support
the collection and reporting on MEPI to include necessary output, outcome, and
impact data elements as well as data on trainee careers? How will proposed
public-private partnerships, coalitions, and networks of African scientists and
educators in leadership roles support collaboration with and enlist the
cooperation of Ministries of Health and Education across Sub-Saharan Africa?

Approach. Are the overall strategy, methodology,
and analyses well-reasoned and appropriate to accomplish the specific aims of
the project? Are potential problems, alternative strategies, and
benchmarks for success presented? If the project is in the early
stages of development, will the strategy establish feasibility and will particularly
risky aspects be managed? If the project involves clinical research, are the
plans for 1) protection of human subjects from research risks, and 2) inclusion
of minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed? How will the applicant conduct
annual assessments to determine technical support needs and best practices for Programmatic
and Linked awards and complete a comprehensive evaluation of the overall program
by the final year of the project? Is there appropriate logistical support to
plan necessary grantee meetings, site visits, and conference calls?

Environment. Will the scientific environment in which the work will be
done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? How does the selected African partner(s) add to the technical merit of the
application and what is the African partner’s capacity to function in the CC
role by the end of the initial 5-year project period? Will the applicant be in a position to offer potential
training opportunities to faculty and students in the Programmatic and/or Linked
awards and support building local evaluation capabilities?

Additional Review Criteria

The following applies to
applicants for each Programmatic and Linked Award as well as the Coordinating Center.

As applicable for the project proposed,
reviewers will consider the following additional items in the determination
of scientific and technical merit, but will not give separate scores for these
items.

Protections for Human Subjects. For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical
research, the committee will evaluate the proposed plans for inclusion of
minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia.For
additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or
procedures proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmission
Applications. Resubmission applications are
not permitted in response to this FOA.

Renewal Applications.Renewal applications are not permitted in response to this
FOA.

Revision Applications. Not applicable to this FOA.

Additional Review Considerations

The following applies to applicants
for each Programmatic and Linked Award as well as the Coordinating Center.

As applicable for the project proposed,
reviewers will address each of the following items, but will not give scores
for these items and should not consider them in providing an overall
impact/priority score.

Applications from Foreign Organizations. Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agents Research. Reviewers will assess the information provided in this
section of the application, including 1) the Select Agent(s) to be used in the
proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period Support. Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research and research training.

Training in the Responsible Conduct of
Research:Reviewers will evaluate
plans for instruction in responsible conduct of research as well as the past
record of instruction in responsible conduct of research, where
applicable. Reviewers will specifically address five Instructional
Components (Format, Subject Matter, Faculty Participation, Duration and
Frequency), taking into account the characteristics of institutional programs or
the unique circumstances for short-term training programs, detailed in NOT-OD-10-019.
The review of this consideration will be guided by the principles set forth in NOT-OD-10-019.
Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant
provides an acceptable, revised plan. See also:
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html.

Selection Process

Applications submitted in response to this FOA will compete
for available funds with all other recommended applications
submitted in response to this FOA. The following will be considered in making funding
decisions:

Scientific
and technical merit of the proposed project as determined by peer review.

Diversity or variation of educational models and
innovation to be awarded.

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official.

Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. See Also Section IV.5. Funding Restrictions.

FIC/NIH and HAB/HRSA will work together
to support awardees’ activities, and this will be closely coordinated with
OGAC, although some awards will be administered directly by FIC/NIH and others
directly by HAB/HRSA. The Linked awards funded by the Common Fund or awards supported by the OAR through this
initiative will be administered by the FIC on behalf of the NIH.

Web-based monitoring, evaluation, and
reporting system: Programmatic
and Linked Awardees are expected to work with the Coordinating Center to
document and report on progress (to include tracking faculty and student
recruitment, training, retention, and practice/research efforts) under the
grant. The CC will develop a web-based monitoring, evaluation, and reporting
system for this purpose. Curriculum development, training, publications and
other significant accomplishments of the program and trainees must be reported
and described in annual progress reports. The CC will coordinate the collection
of this data to use in assessing and evaluating how the overall objectives of
the MEPI are being met.

A
final progress report, invention statement, and Financial Status Report are
required when an award is relinquished, when a recipient changes institutions,
or when an award is terminated.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research (program), peer review, and financial or
grants management issues:

Early Conference calls open to all potential applicants
will be held on pre-selected dates. Please see (www.fic.nih.gov) for
additional information.

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules, as
well as local, State and Federal laws and regulations, including the Privacy
Rule.

Policy
for Genome-Wide Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.

Access
to Research Data through the Freedom of Information Act:The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide public
access to research data through the Freedom of Information Act (FOIA) under
some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of
Model Organisms:NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.

Inclusion of
Women And Minorities in Clinical Research:It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of
Children as Participants in Clinical Research:The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.

Required
Education on the Protection of Human Subject Participants:NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.

Standards
for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy
People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372. Awards are made under Sections 301 and
405 of the PHS Act, as amended (42 USC 241 and 284) and are subject to 42 CFR
Part 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement. The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.